- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07691411
An Ecological Momentary Assessment Based Program to Support Self-Management for Post-stroke Patients
Combining Machine Learning and Ecological Momentary Assessment of Depression, Cognitive Function and Daily Activity Behavior to Support Self-Management for Post-stroke Patients: A Feasibility Study
The goal of this feasibility study is to test whether a new approach that combines real-time symptom tracking (Ecological Momentary Assessment) with machine learning can help people recovering from a stroke to better manage depression, thinking difficulties, and daily functioning. The main questions it aims to answer are:
Is this combined approach practical and acceptable for post-stroke survivors? Does the program improve mood, cognitive function, or functional ability to carry out daily activities?
Participants will:
Use a smartphone app called RehabCare Companion for a period of time Answer brief daily surveys about their mood, thoughts, and activities for one week Receive personalized self-care suggestions generated by machine learning based on their responses Complete assessments of depression, cognition, and functioning before and after the program Take part in a group interview to share their experiences
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Arkers KC Prof. Wong, PhD
- 전화번호: +852 34003805
- 이메일: arkers.wong@polyu.edu.hk
연구 연락처 백업
- 이름: Nuo Dr. Shi, DHSc
- 전화번호: +852 34008172
- 이메일: nuo-catherine.shi@polyu.edu.hk
연구 장소
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Hong Kong
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Hong Kong, Hong Kong, 홍콩, 999077
- 모병
- Queen Elizabeth Hospital
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연락하다:
- Vivian WY Ms. Kwok
- 전화번호: +852 34003805
- 이메일: arkers.wong@polyu.edu.hk
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- adults aged 18 years or older
- having a confirmed diagnosis of stroke
- having sufficient proficiency in Cantonese to understand and respond to the assessments and prompts
- having a Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA) score of 18 or higher
- having a smartphone.
Exclusion Criteria:
- they have moderate to severe cognitive impairment (a HK-MoCA score of 17 or lower)
- they have active psychiatric disorders other than depression (e.g., schizophrenia, bipolar disorder)
- they have a terminal illness or prognosis that suggests a limited life expectancy
- they have conditions that compromise their self-care ability (i.e., bedbound).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Ecological Momentary Assessment based Self-management Program
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The research team collects participants' EMA data (ie., depression, cognitive function, daily activity, and contextual data) from participants for 7-day and analyze the data by machine learning in the first phase, while provide real-time, individualized, self-care messages to the participants via a personalized self-care AI app in the second phase.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility of the study: acceptance
기간: Immediately after the intervention (T2).
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The acceptance of participants to the program will be measured by recruitment rate, attrition rate, and retention rate.
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Immediately after the intervention (T2).
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Feasibility of the study: adherence
기간: Immediately after the intervention (T2).
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The adherence of the participants will be evaluated by using the percentage of completed EMA assessments and the frequency of app usage.
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Immediately after the intervention (T2).
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Feasibility of the study: experience of the participants in using the app
기간: Immediately after the intervention (T2).
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Participants' experience will be assessed through individual interviews.
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Immediately after the intervention (T2).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Preliminary effectiveness: depression Levels
기간: Pre-intervention (T1) and immediately after the intervention (T2).
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Beck Depression Inventory (BDI) will be used to assess the depression levels of post-stroke patients.
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Pre-intervention (T1) and immediately after the intervention (T2).
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Preliminary effectiveness: cognitive function
기간: Pre-intervention (T1) and immediately after the intervention (T2).
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Cognitive function will be screened using Montreal Cognitive Assessment Hong Kong version (HK-MoCA).
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Pre-intervention (T1) and immediately after the intervention (T2).
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Preliminary effectiveness: disability and functioning
기간: Pre-intervention (T1) and immediately after the intervention (T2).
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The World Health Organization Disability Assessment Schedule (WHODAS 2.0) is a widely used instrument for assessing disability and functioning in individuals.
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Pre-intervention (T1) and immediately after the intervention (T2).
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공동 작업자 및 조사자
수사관
- 수석 연구원: Arkers KC Wong, PhD, The Hong Kong Polytechnic University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .